Effectiveness of the Distraction Methods During Cystoscopy

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi (Other)

Overall Status

Completed

CT.gov ID

NCT02764294

Collaborator

(none)

120

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Cystoscopy is a pain procedure and patients may experience anxiety and dissatisfaction before and during the procedure. Especially male patients feel more pain than females during cystoscopy. The aim of this study is to compare effectiveness of three different distraction methods on pain, anxiety and satisfaction of the male patients during cystoscopy.

Condition or Disease	Intervention/Treatment	Phase
Pain Anxiety Satisfaction	Other: Music Group Other: Stress Ball Group Other: DVD Group	N/A

Detailed Description

Cystoscopy is a reliable and effective method used commonly to investigate tumors and pathological or suspicious views related to bladder and urethra. The patients may feel pain, anxiety and dissatisfaction when cystoscope is inserted into the bladder. Thus nonpharmacological and pharmacological methods are used to decrease pain, anxiety and dissatisfaction levels of the patients during the procedure. Music is the most commonly used distraction method during cystoscopy, but there are few studies in this issue (only music) on literature. In additon, there isn't any study related to stress ball use during cystoscopy and there isn't any study which comparatives effectiveness of the multiple distraction methods to reduce pain, anxiety and dissatisfaction levels during this procedure. Therefore the investigators aimed to compare effectiveness of three different distraction methods (music, stress ball and DVD) on pain, anxiety and satisfaction of the patients during cystoscopy.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Effectiveness of the Distraction Methods on Pain, Anxiety and Satisfaction During Cystoscopy

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Music Group Music group was listened to a music of their choise with a headset. The music intervention was started about 10-15 minutes before cystoscopy and continued during the whole procedure. Types of music were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music.	Other: Music Group Music group was listened to a music of their choise with a headset. The music intervention was started about 10-15 minutes before cystoscopy and continued during the whole procedure. Types of music were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music.
Active Comparator: Stress Ball Group Stress ball group was given stress ball into both their palms about 10-15 minutes before cystoscopy. Participants were instructed to "squeeze the balls twice after counting up to five" and "repeat it until the end of the procedure".	Other: Stress Ball Group Music group was given stress ball into both their palms about 10-15 minutes before cystoscopy. Participants were instructed to "squeeze the balls twice after counting up to five" and "repeat it until the end of the procedure".
Active Comparator: DVD Group DVD group was watched a DVD of their choice (documentaries, interesting and amazing videos, comedies) on a ceiling-mounted monitor positioned at a comfortable distance to the participant.	Other: DVD Group DVD group was started to be watched a DVD of their choise about 10-15 minutes before cystoscopy and continued during the whole procedure.
No Intervention: Control Group Participants received usual care from health professionals. They didn't receive any intervention.

Outcome Measures

Primary Outcome Measures

Pain Measure ["5-10 minutes before", "during" and "5 minutes after" cytoscopy]
The average score change on pain intensity as measured by VAS scale.

Secondary Outcome Measures

Anxiety Measure ["5-10 minutes before" and "5 minutes after" cytoscopy]
The average score change on anxiety level as measured by STAI-State Anxiety scale.
Satisfaction Measure ["5 minutes after" cytoscopy]
The average score change on satisfaction level as measured by STAI-State Anxiety scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

to be male and over 18 years old
to be first csytoscopy
to be rigid csytoscopy

Exclusion Criteria:

to have a contradiction for csystoscopy (lidocaine allergies, urinary tract infection, no anatomical problems with the urethra etc.)
to be used any analgesic drug at least 24 hours prior to cystoscopy
to be made manipulations such as double j stent placement or removal, and bladder biopsy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

Principal Investigator: Elif Gezginci, RN, PhD, University of Health Sciences, Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey